Determining the Mechanisms of Loss of CAR T Cell Persistence
CARPERS
1 other identifier
observational
50
1 country
3
Brief Summary
A prospective observational study of pediatric and young adult acute lymphoblastic leukaemia (ALL) patients treated with CD19 chimeric antigen receptor T-cells (CAR-T cells). The study will examine changes in CAR-T persistence over time and causal factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2023
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedStudy Start
First participant enrolled
October 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMay 23, 2024
May 1, 2024
2.1 years
March 3, 2023
May 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Time to circulating CAR-T cell loss
CAR-T persistence will be measured in the central lab from blood samples.
Through study completion, until the last patient reaches 1 year post-infusion
Eligibility Criteria
The study population is paediatric and young adult patients aged 25 or younger who have relapsed/refractory B-cell acute lymphoblastic leukaemia.
You may qualify if:
- Children and young adults (age 25 years or younger) with relapsed/refractory ALL who are planned to receive licensed CD19-targeted CAR-T cell treatment (Tisagenlecleucel)
- Written informed consent
You may not qualify if:
- Patients receiving an alternate CD19-directed CAR T-cell product on a clinical trial
- Any reason that in the opinion of the investigator, patients won't be able to adhere to the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Great Ormond Street Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
Biospecimen
Excess CAR-T samples following infusion Blood samples will be collected at protocol timepoints
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Persis Amrolia, BSc,MBBS,PhD
UCL Institute of Child Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2023
First Posted
April 12, 2023
Study Start
October 18, 2023
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
May 23, 2024
Record last verified: 2024-05